Abstract
BackgroundMany studies were conducted to assess the benefit/risk ratio of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) in France before it was authorized for use outside the hospital setting in 2009. The main objective of this project is to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. The secondary objectives are to (i) evaluate the appreciation of EMONO by the children, (ii) characterize children who experience both analgesia and anxiolysis, (iii) evaluate children’s appetite for EMONO and characterize children with a high appetite and (iv) evaluate the impact of the difference in practice among the French dental service university hospitals on anxiety. The maintenance of a framework for the safe use of this drug, whose place in dental care is fundamental, is essential. Twelve of the 16 French dental service university hospitals agreed to participate in this study.MethodsMEOPAeDent is an observational, descriptive, transversal study that aims to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. Subjects requiring dental care under EMONO are recruited by 12 French dental service university hospitals. Patients aged from 3 to 15 years are recruited for the study when they visit a dental service of a French university hospital requiring dental care under EMONO. The investigator collects the necessary data from the child’s medical records, from his own observations and from questions posed to the child and his/her parents. A survey is completed at the first and final sessions of dental care under EMONO.DiscussionThis study will provide an evaluation of the effects of EMONO on the French paediatric population in need of dental care as well as evaluate the appetite for the use of this substance. The results will first be used to provide additional data that is essential to monitor the use of a product with an authorization to use it outside of hospitals from 2009 in France, confirm its safety for use and justify its framework of application.Trial registrationClinicalTrials.gov ID: NCT03453411 registered 2 March 2018.
Highlights
Many studies were conducted to assess the benefit/risk ratio of Equimolar mixture of oxygen and nitrous oxide (EMONO) (Equimolar Mixture of Oxygen and Nitrous Oxide) in France before it was authorized for use outside the hospital setting in 2009
EMONO is an equimolar mixture of oxygen and nitrous oxide available in France for dental care
The main objective of this project is to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry
Summary
Many studies were conducted to assess the benefit/risk ratio of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) in France before it was authorized for use outside the hospital setting in 2009. EMONO is an equimolar mixture of oxygen and nitrous oxide available in France for dental care. It has an analgesic effect with a reduction of the perception threshold of different painful stimuli and an anxiolytic effect. Based on the product characteristics summary available in the French government’s public drug database [base-donnees-publique.medicaments.gouv.fr/], EMONO indications in dentistry are dental care for infants, children and adolescents, as well as for anxious and patients with disabilities. Patient cooperation tends to improve under EMONO and, when not used in conjunction with psychotropic agents [6–8], the use of EMONO is safe
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